FDA Panel Backs Giving HPV Vaccine Gardasil to Young Males

Sept. 11

By Amanda GardnerHealthDay Reporter

WEDNESDAY, Sept. 9 (HealthDay News) -- U.S. drug advisors recommended Wednesday that use of the vaccine Gardasil, already administered to help prevent cervical cancer in women, be expanded to help prevent genital warts in young males.

A U.S. Food and Drug Administration advisory panel voted to recommend the expanded use of the vaccine for males 9 to 26. The FDA is not required to follow its advisory panels' recommendations, but it typically does.

The vaccine targets the human papilloma virus, which can cause genital warts in both males and females, cervical cancer in women and also penile and anal cancer in men -- although these remain much rarer than cervical malignancies.

The vaccine is manufactured by drug maker Merck & Co.

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Merck had asked the FDA to approve Gardasil for males ages 9 to 26. It is already approved in females 9 and older to help prevent cervical cancer.

Before the Gardasil vote, the committee on Wednesday also voted that a second HPV vaccine, GlaxoSmithKline's Cervarix, seems safe for girls and women ages 10 to 25 for the prevention of cervical cancer. Studies have shown that the vaccine prevents infection with HPV 93 percent of the time. The introduction of Cervarix was delayed in 2007 when the FDA said it needed more research on the vaccine.

The FDA advisors -- comprising the Vaccines and Related Biological Products Advisory Committee -- said Wednesday that newer studies suggest the Cervarix vaccine is safe, but they recommended follow-up studies to look for miscarriages and muscular problems reported by a small number of patients, the Associated Press reported.

The vote to expand the use of Gardasil to males was not unexpected among health experts.

"It is really hard to get a read on these things, but I don't think anybody is going to be shocked if eventually this is extended to boys, especially since the science is pretty solid here," Fred Wyand, a spokesman for the American Social Health Association, in Research Triangle Park, N.C., said before the vote.

"I would not be surprised at all if FDA approved the new indication," agreed Dr. Jonathan L. Temte, a professor of family medicine at the University of Wisconsin School of Medicine and Public Health in Madison.

Temte is also a voting member of the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) and explained that if the FDA approves the new use for males, the CDC committee can expect to see the item on its agenda in October.

Health experts believe it makes sense to vaccinate boys against the HPV virus.

"We're supportive in general of giving vaccines to boys for a number of reasons," Wyand said. "Clinical trials have shown it's pretty effective -- 90 percent effective in preventing genital lesions [in boys]. Trials in a subset of gay men also found the vaccine to be effective in preventing external lesions, so the signs are pretty clear that it works in guys."

Vaccinating boys would help shield girls, too, the experts added.

"It's a sexually transmitted disease, and it takes two people to transmit the virus," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "If the vaccine can reduce the risk of infection in men as well as women, then I believe it should be given to both men and women."